Medical device manufacturing is a highly regulated field where product safety, quality, and compliance are critical. ISO 13485 is the internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It outlines the requirements for consistent design, development, production, installation, and servicing of medical devices.
One important aspect of ISO 13485 is the requirement for record retention. These records serve as evidence of compliance, product history, and traceability, ensuring that manufacturers can respond to audits, customer inquiries, and regulatory investigations.
If you are looking for ISO 13485 Certification in Bangalore, understanding the record retention requirements is vital to building and maintaining a compliant QMS. Let’s break down what the standard says and what it means for your business.
ISO 13485 requires organizations to retain records that demonstrate conformity to product requirements and the effectiveness of the QMS. Specifically, clause 4.2.5 of ISO 13485:2016 states:
Records shall be retained for at least the lifetime of the medical device as defined by the organization or as required by applicable regulatory requirements, but in no case less than two years from the date of product release.
In simpler terms:
For example:
Medical device records are not just paperwork—they are the proof that your organization consistently produces safe, compliant, and effective products.
Key reasons for maintaining these records include:
Many regulatory authorities, including the FDA (United States), EU MDR (Europe), and CDSCO (India), require manufacturers to keep manufacturing and design records for extended periods. ISO 13485 helps align your QMS with these requirements.
If there is a recall, complaint, or adverse event report, retained records allow manufacturers to trace specific batches, materials, and processes used in the device’s production.
Records can serve as evidence in legal proceedings, protecting the company against liability claims by demonstrating compliance and due diligence.
Certification bodies and regulatory agencies may request historical records during audits. Being prepared can prevent nonconformities and certification risks.
ISO 13485 requires a variety of records related to manufacturing and quality control to be retained, including:
While ISO 13485 provides the “at least two years” rule, the actual retention period may vary depending on:
For organizations seeking ISO 13485 Services in Bangalore, following these best practices ensures compliance:
Achieving and maintaining ISO 13485 compliance can be complex, especially when interpreting retention rules across different markets. ISO 13485 Consultants in Bangalore can help by:
Under ISO 13485, manufacturers must retain records related to the manufacture of medical devices for at least the lifetime of the device or as required by applicable regulations, but not less than two years from the product’s release date.
For companies aiming for ISO 13485 in Bangalore, proper record retention is not just a compliance necessity—it is a safeguard for product quality, regulatory approval, and business reputation. Partnering with professional ISO 13485 Services in Bangalore ensures your record management processes meet international standards and local regulations, helping you maintain trust and compliance in the competitive medical device industry.